Medical Devices & Biosafety
Medicinsk udstyr og biosikkerhed
Biosafety of medical devices
- Research, drafting, and editing of medical device documentation
- Biological Evaluation Plans and Biological Evaluation Reports according to MDR and appropriate ISO 10993 standards
- MDD to MDR for biological evaluation
Material biocompatibility
- Chemical composition of materials from datasheets and literature, history of use, review of constituents, including restricted substances
- Toxicological Risk Assessment
Quality documentation
- Drafting and editing of QMS documentation, such as SOPs, Work Instructions, Quality System Procedures, and Quality System Instructions according to ISO 13485
Non-disclosure agreement and full confidentiality will be applied
info@scriptora.dk
